Online Dietary and Resistance Training to Improve Physical Function in Older Cancer Survivors, E-PROOF Trial

The Ohio State University

Status

Completed

Conditions

Stage I Prostate Cancer AJCC v8

Anatomic Stage III Breast Cancer AJCC v8

Anatomic Stage II Breast Cancer AJCC v8

Stage I Colorectal Cancer AJCC v8

Stage III Prostate Cancer AJCC v8

Anatomic Stage I Breast Cancer AJCC v8

Stage II Colorectal Cancer AJCC v8

Stage II Prostate Cancer AJCC v8

Stage III Colorectal Cancer AJCC v8

Treatments

Other: Quality-of-Life Assessment

Other: Nutritional Assessment

Other: Questionnaire Administration

Other: Informational Intervention

Other: Physical Performance Testing

Other: Exercise Intervention

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT06016725

R21AG078258 (U.S. NIH Grant/Contract)

NCI-2023-04622 (Registry Identifier)

OSU-22329

Details and patient eligibility

About

This phase I trial tests the feasibility, acceptability, and preliminary effectiveness of online dietary and resistance training to improve physical function in older (greater than or equal to 65-years old) cancer survivors. Declines in adequate protein and calorie intake results in faster loss of muscle mass and physical functioning in older adults. A novel approach to improving physical function in older cancer survivors (OCS) is to utilize online, tailored education and counseling from registered dietitians and exercise scientists, to improve dietary intake (protein intake, diet quality) and participation in resistance exercise. The purpose of this study is to help researchers learn whether an online dietary and resistance training intervention improves diet, exercise, physical function, and health outcomes in OCS.

Full description

PRIMARY OBJECTIVES:

I. Determine the feasibility and acceptability of implementing a 12-week online dietary and resistance training randomized trial with 70 older cancer survivors.

II. Examine the preliminary efficacy of this 12-week online dietary and resistance training intervention with the intervention participants.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM 1: Patients participate in online nutritional counseling over 30 minutes in weeks 1, 3, 5, 7, 9, and 11, and participate in online resistance training sessions weekly over 30 minutes in weeks 1-6 and biweekly at weeks 8, 10, and 12. Patients also receive educational materials at baseline.

ARM 2: Patients receive educational materials at baseline.

After completion of study intervention, patients are followed up at 3 months.

Enrollment

75 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

>= 65 years of age
A primary diagnosis of stage I-III breast, colorectal, and prostate cancer
Completion of primary curative treatment
Reported at least 1 physical function limitation on the RAND-36 Physical Function Subscale (PFSS) ("limited a little", "limited a lot")
No evidence of progressive disease or second cancers
Community-dwelling
Able to provide consent

Exclusion criteria

Currently receive cancer treatment (e.g., chemotherapy, radiation)
Have liver and/or renal disease limiting their protein intake
Are under the care of a Registered Dietician (RD)/nutritionist
Participating in other diet/exercise interventions
Consume protein supplements
Have contraindications to unsupervised exercise (e.g., walker/wheelchair use)

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

75 participants in 2 patient groups

Arm 1 (nutritional counseling, resistance training)

Experimental group

Description:

Patients participate in online nutritional counseling over 30 minutes in weeks 1, 3, 5, 7, 9, and 11, and participate in online resistance training sessions weekly over 30 minutes in weeks 1-6 and biweekly at weeks 8, 10, and 12. Patients also receive educational materials at baseline.

Treatment: